CMD(h) BEST PRACTICE GUIDE FOR THE PUBLIC …

Co-ordination Group for Mutual Recognitionand decentralised Procedures - HumanCo-ordination Group for Mutual Recognitionand decentralised Procedures - Human CMD(h) best PRACTICE GUIDE FOR THE PUBLIC assessment report IN THE decentralised AND MUTUAL RECOGNITION PROCEDURES January 2006 According to Art 21 (3) and (4) of Directive 2001/83 as amended the competent authorities shall make publicly available a PUBLIC assessment report (PAR) of marketing authorisations issued via the Mutual Recognition Procedure (MRP) or the decentralised Procedure (DCP). These articles read as: 3. The competent authorities shall make publicly available without delay the marketing authorisation together with the summary of product characteristics for each medicinal product which they have authorised. 4. The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and preclinical tests and the clinical trials of the medicinal product concerned.

Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human CMD(h) BEST PRACTICE GUIDE FOR THE PUBLIC ASSESSMENT REPORT IN THE DECENTRALISED AND MUTUAL RECOGNITION PROCEDURES

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